In order to maximize the interoperability of anonymized data and reduce the contractual barriers and administrative burden(s) of data sharing, the MRCT Center developed three harmonized governance tools as part of the PCORI Open Science Pilot Project. > MORE

The second Research, Development, and Regulatory Roundtable (R3) was held at the New York City offices of Ropes & Gray LLP On November 8, 2018. Stakeholders convened to discuss Right to Try vs. Expanded Access: Practical, Legal, and Regulatory Considerations.

The MRCT Center Bioethics Collaborative is delighted to share a very brief summary of the April 24, 2018 discussion related to Return of Individual Results to Research Participants and Axes of Communication. Read the summary here

In April 2018, the MRCT Center held a 3 1/2-day training workshop at the Harvard Faculty Club focused on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP) as an APEC (Asia-Pacific Economic Cooperation) Pilot Center of Excellence (CoE), and specifically on ICH-E17 and ICH-E6(R2).

The MRCT Center, in collaboration with TransCelerate Biopharma, Inc. submitted to FDA for consideration a draft guidance document on provision of plain language summaries for study participants. > MORE

We have released the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines. This framework consists of two parts: a Guidance Document (Version 1.1) and a Toolkit (Version 1.0) .

The Joint Task Force for Clinical Trial Competency (JTF) has released the Draft Version 2.0 of the Harmonized Core Competency Framework for public comment. This is an effort of a multi-stakeholder, widely representative workgroup from across the global clinical research community. > MORE

The MRCT Center, in collaboration with Harvard University and the Association of American Medical Colleges (AAMC), released a Sounding Board in the New England Journal of Medicine on the concept of data authorship, a designation and system of credit meant to recognize the efforts the data generators and data sharers.

The MRCT Center 2016 Annual Meeting was held on December 7, 2016 and was attended by about 80 stakeholders, including representatives from academia, governmental agencies, institutional review boards, the pharmaceutical industry, and non-profit organizations.

The MRCT Center is pleased to announce that we have received endorsement to become a Pilot Center of Excellence (CoE) at the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) SOM1 Meeting in Nha Trang, Vietnam.

The MRCT Center Individual Return of Results workgroup developed principles that are directly relevant to the return of individual research results to research participants. These principles are summarized in a brief Principles Document.

In January 2017, MRCT Center Faculty Co-Directors, Dr. Barbara Bierer and Mark Barnes, JD, co-authored with Abram Barth and David Peloquin an article entitled, “HHS Finalizes Comprehensive Revisions to the Common Rule” published in Bloomberg BNA Life Sciences Law & Industry Report.

On December 7, 2016, at the MRCT Center Annual Meeting, we released Version 1.0 of the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines – Guidance Document. > MORE

On October 19, 2016, 52 participants from academia, industry, non-profit organizations, professional associations and regulatory agencies gathered at Harvard Faculty Club for a workshop on “Core Competencies in Clinical Research: Real World Applications, Convergence and Evolution of Framework.” > MORE

The MRCT Center will host a workshop to discuss the evolution of a harmonized framework of core competencies for clinical research professionals and its application to real world experiences. Fifteen real life case studies applying the core competencies by industry, professional societies and academia in the US and global settings will be presented.

A multi-stakeholder work group, led by the MRCT Center, discussed over the last six months issues relevant to returning individual results of clinical trials to participants. We have drafted an initial set of eight principles that are directly relevant to the return of individual results and that are open for comment.

In 2014, the MRCT Center convened a multi-stakeholder workgroup to develop a Guidance Document and Toolkit for returning aggregate results to trial participants. The Guidance Document and Toolkit were released in March 2015 and, since then, modified in response to questions, suggestions, and continued progress in the field. > MORE

The MRCT Center, in collaboration with The Wellcome Trust, held a conference on “The Future of Clinical Trials Data Sharing” in London, U.K., March 21-22, 2016 with approximately 100 participants from academia, government, not-for-profit organizations, journal editors and industry. > MORE

On March 21-22, 2016 at an invitation-only meeting at the Wellcome Trust in London, the MRCT Center and collaborators shared plans to launch a new not-for-profit organization, Vivli, charged with directing, implementing and governing a global clinical trial data-sharing platform. The plans for an approach whereby data from multiple sources can be integrated, enabling researchers to access and combine data across various platforms were deliberated. > MORE

The MRCT Center is launching a new initiative–the Bioethics Collaborative.

The MRCT Bioethics Collaborative is a forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development. Our meetings will bring together scholars, executives, and scientists from academia and industry to share, define, study, and propose ethical frameworks for topics including human subject protections, biospecimens, and research integrity. We will look at real-life settings as well as develop approaches to address emerging and unanticipated issues as the pace of research continues to accelerate. The Collaborative will be a neutral forum to provide ethical guidance on global clinical trials concerns. > MORE

The MRCT Center 2015 Annual Meeting was held on 15 December 2015 and was attended by about 70 stakeholders from academia, governmental agencies, pharmaceutical industry, patient advocates, non-profit organizations, institutional review boards and others. The MRCT Center 2015 Annual Progress Report was released at the meeting.

A multi-stakeholder team, convened by the MRCT Center, published an article detailing use of a Protocol Ethics Toolkit to facilitate effective recognition, consideration and deliberation of critical clinical ethical issues in clinical trial protocols.

The 2015 Awards for Excellence in Human Research Protection were announced on December 28th by Dr. Peter G. Goldschmidt, President and Founder of Health Improvement Institute, “The award program recognizes submissions that our judging panel determines have demonstrated excellence in promoting the well-being of human research participants.”

The MRCT Center and Peking University collaborated to develop a framework, harmonized to guidance from ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), regarding how countries can consider the importance of ethnic factors, trend consistency and the definition of region in the evaluation on drug efficacy and safety for the design of multi-regional clinical trials.

The MRCT Center will hold its 2015 Annual Conference in December. This conference offers Executive and Steering Committee and Working Group members as well as interested stakeholders the opportunity to meet face-to-face with each other and learn about current projects of the MRCT Center.

The Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital (MRCT Center), the Wellcome Trust, and the Arnold Foundation have spearheaded a major initiative related to sharing of clinical trials data, to enable stakeholders to comply with PhRMA, EFPIA, EU and IOM guidelines on clinical trial data sharing: sharing participant level data with researchers.

As of July 1, 2015, the MRCT Center has moved administratively to the Division of Global Health Equity, under the leadership of Dr. Paul Farmer, at the Brigham and Women’s Hospital (BWH), a Harvard teaching hospital. The Division of Global Health Equity serves as an academic and research home for more than 40 Harvard and BWH faculty who are engaged in teaching, patient care and research around the world and domestically.

The Post-Trial Responsibilities Working Group, sponsored by the MRCT Center at Harvard, was launched in February 2015 and is a multi-stakeholder group with 55 members from academia, industry, non-profit organizations, government, and patient organizations. Twelve countries are represented.

On March 30-31st, 2015, over seventy committed international stakeholders joined together at the Harvard Faculty Club in Cambridge Massachusetts to deliberate how to promote and coordinate clinical trials data transparency. Over the two day conference, renowned experts from academia, industry and others shared their organizational experiences in data sharing, distilled best practices, described lessons learned from case studies, reviewed recommendations from the Institute of Medicine report: Strategies for Responsible Sharing of Clinical Trial Data, and considered how best to put those recommendations into practice.

There are multiple ethical challenges for conducting multi-regional clinical trials in developing countries, such as whether patients in developing countries are free to participate in research if access to essential medicines is tied to research, and how informed consent can be assessed and risks and benefits understood when the element of choice is so different.

More than 70 participants from academia government, industry, and nonprofit organizations gathered at the Harvard Faculty Club for a 2-day conference focused on how to harness the full potential of participant level data sets for secondary use.

In March, we submitted public comments to the National Institutes of Health in response to the Proposed Rule for Clinical Trial Registration and Results Submission. Our comments addressed the need for:

The MRCT Center at Harvard continues its active engagement in India. Most recently, important efforts to address regulatory issues have been expanded to develop tools and capacity in causality assessment of adverse events that occur during participation in clinical trials.

MRCT Center at Harvard 2014 Annual Meeting was held on 3 December 2014 and was attended by by more than 60 stakeholders from governmental agencies, pharmaceutical industry, academia, patient advocates, media representatives and others. MRCT Center at Harvard’s Annual Progress Report 2014 was released at the meeting.

MRCT Center at Harvard collaboratively with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School hosted a one-day open conference on post-trial responsibilities on September 18, 2014, at the Harvard Law School.

MRCT Center at Harvard was asked to present their efforts on clinical trial data sharing at IOM on February 3, 2014. Both presentations were well received, and the IOM was receptive to suggestions made by MRCT.

MRCT Center at Harvard, the All India Institute of Medical Sciences (AIIMS) and Apollo Hospitals Research and Education Foundation (AHREF) co-hosted a two day roundtable to discuss issues surrounding clinical trials in India. The very productive sessions resulted in the attached Executive Summary and discussions with the Ministry of Health in India.

Boston, MA – A new report by researchers from Harvard University and others in a working group convened by the Multi-Regional Clinical Trials Center (MRCT) at Harvard proposes recommendations for addressing a problem that has vexed drug regulators: how to expand public access to data from clinical trials while protecting patients’ privacy and weighing pharmaceutical companies’ business interests.

MRCT Center at Harvard Informed Consent Subgroup has submitted comments on EMA Draft Policy 0070. This subgroup is part of the second phase of MRCT’s efforts related to Clinical Trial Data Sharing and Transparency, called “Implementation and Solutions”.

Harvard University’s Multi-Regional Clinical Trials Center (MRCT) submitted the following comments on FDA’s proposal, 78 Fed. Reg. 33421 (June 4, 2013), to make de-identified and masked clinical and preclinical data, from marketing applications submitted to FDA, available to external experts and others, as part of the Agency’s transparency initiative.

The Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions Conference, held on May 17th, 2013, drew close to 200 participants and proved to be an exceptional platform to discuss matters surrounding clinical trial data sharing.

The Multi-Regional Clinical Trial Center at Harvard has an initiative focused on training of Data Safety Monitoring Board (DSMB) members; this initiative is driven by a working group comprised of stakeholders from industry and academia and the 2013 class of DSMB Fellows were equally as diverse.